NCT04510350已完成不适用
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Frequency of immune subpopulations
研究概览
简要总结
The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
- •At least 18 years of age
- •Diagnosed with MS according to criteria 2017 at the time of their last visit.
- •Non-opposition to participation in the study
- •Having had at least one visit in the year following collection
- •Follow-up for at least 1 year after collection.
- •Having signed the OFSEP consent
排除标准
- •CIS patients with progressive MS
- •Healthy volunteers :
- •Inclusion Criteria:
- •Age 18 years or older
- •Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
- •Matched on age and sex to patients of interest in the OFSEP cohort
- •Not having objected to participation in the study
- •Exclusion Criteria:
- •Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
结局指标
主要结局
Frequency of immune subpopulations
时间窗: 1 year
Correlations between the frequency of immune subpopulations, genetic profile and disease activity
次要结局
- Frequency of immune subpopulations correlated to EDSS score(1 year)
- Frequency of immune subpopulations correlated to disease progression delay(1 year)
- Profiles of CIS+ patients(1 year)
- Frequency of immune subpopulations correlated to disease progression events(1 year)
- Frequency of immune subpopulations correlated to spinal lesions(1 year)
研究者
研究点 (1)
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